Suturing instrument and method for uterine preservation

ABSTRACT

A suturing instrument includes an elongate body member, a needle deployment mechanism, and a depth adaptor. The elongate body member includes a distal portion that defines an opening. The needle deployment mechanism is at least partially disposed within the elongate body member and moves the needle out of the suturing instrument and into tissue. The depth adaptor is disposed in the opening at the distal portion of the elongate body member and controls the depth that the needle penetrates into the tissue.

CROSS-REFERENCE TO RELATED CASE

This application claims priority to, and the benefit of Provisional U.S.Patent Application Ser. No. 61/060,556, filed Jun. 11, 2008, theentirety of which is incorporated herein by reference.

TECHNICAL FIELD

The invention relates generally to devices and methods for placingsutures, and in particular to devices and methods for treating variouspelvic dysfunctions including procedures to repair uterine prolapse,cystoceles, rectoceles, and vaginal vault prolapse.

BACKGROUND INFORMATION

Suturing of body tissue is a time consuming aspect of many surgicalprocedures. For many surgical procedures, it is necessary to make alarge opening in the human body to expose the area that requiressurgical repair. There are instruments available that allow for viewingof certain areas of the human body through a small puncture woundwithout exposing the entire body cavity. These instruments, calledendoscopes, can be used in conjunction with specialized surgicalinstruments to detect, diagnose, and repair areas of the body thatpreviously required open surgery to access.

Some surgical instruments used in endoscopic procedures are limited bythe manner in which they access the areas of the human body in need ofrepair. In particular, the instruments may not be able to access tissueor organs located deep within the body or that are in some wayobstructed. Also, many of the instruments are limited by the way theygrasp tissue, apply a suture, or recapture the needle and suture.Furthermore, many of the instruments are complicated and expensive touse due to the numerous parts and/or subassemblies required to make themfunction properly. Suturing remains a delicate and time-consuming aspectof most surgeries, including those performed endoscopically.

In various corrective surgeries or implant procedures, bodily tissuemust be returned to a normal anatomical position or placed in animproved position. For example, when uterine prolapse occurs, weakenedligaments cause the uterus to descend into the vaginal cavity. One wayto correct uterine prolapse requires that the vaginal apex beapproximated to the sacrospinous ligament. The uterus is suspended bysutures that are passed through the vaginal wall. In certaincircumstances such as, for example, grade two prolapse (small prolapse),passing sutures through the vaginal wall with a free needle and needledriver is often difficult as there is limited space to work in.

A vaginal prolapse can be due to age or other factors and typicallyresults in one of three types of prolapse: hysterocele, cystocele, andrectocele. A hysterocele occurs when the uterus descends into the. Acystocele prolapse occurs when the bladder bulges or descends into thevagina and a rectocele occurs when the rectum bulges or descends intothe vagina. It is often common for more than one of a hysterocele andcystocele, a hysterocele and a rectocele to occur at the same time.Treatment of vaginal vault prolapse, including a vaginal prolapse due toa hysterocele, can include a suturing procedure or the use of an implantfor support or suspension.

Another procedure to treat a prolapse caused by a hysterocele is toperform a hysterectomy. Many patients, however, want to avoid ahysterectomy for a variety of reasons, including plans for futurechildbearing, concern about the invasiveness of the procedure, thedifficulty of the recuperation, or fear of diminished sexual function.Some women are simply reluctant to “give up” this part of their body soclosely associated with their reproductive health, childbearing, andfemininity.

Uterine prolapse can be effectively treated without hysterectomy, withlow morbidity and high rates of patient satisfaction. A properlyperformed uterine suspension procedure often results in a significantlybetter anatomic outcome than a hysterectomy. Yet, many hysterectomyprocedures are performed for pelvic prolapse. Many patients remainunaware of uterine-sparing options because with the exception of a fewdedicated sub-specialists, most surgeons receive no training in thesetechniques. In addition, known techniques can be difficult, and canrequire specialized training that many general practitioners have notundertaken.

SUMMARY OF THE INVENTION

Devices and methods for performing various medical procedures within apelvic region of a patient are described herein. For example, medicalprocedures to treat uterine prolapse, vaginal vault prolapse, rectocele,and cystocele are described herein.

In one aspect, the invention is directed to a suturing instrumentincluding an elongate body member, a needle deployment mechanism, and adepth adaptor. The elongate body member includes a distal portion thatdefines an opening. The needle deployment mechanism is at leastpartially disposed within the elongate body member. The needledeployment mechanism is configured to move a needle out of the suturinginstrument and into tissue of a patient. The depth adaptor is disposedin the opening at the distal portion of the elongate body member andcontrols the depth that the needle penetrates into the tissue.

In various embodiments, the suturing instrument may further include aneedle catch disposed on the distal portion of the elongate body member.The needle catch is configured to receive the needle. In one embodiment,the needle deployment mechanism may also include a needle carrier, andan actuator coupled to the needle carrier. The actuator may be disposedat least partially in a proximal portion of the elongate body member.

In additional embodiments, the elongate body member includes one or morebends. The suturing instrument can be adapted to access remote organs ortissue within a body. The distal portion of the elongate body member canbe rotatable relative to a remainder of the elongate body member.Further, the suturing instrument may include a handle disposed oppositethe distal portion of the elongate body member. The handle can at leastpartially house the needle deployment mechanism. The suturing instrumentcan be used, for example, to access areas within the patient's body toligate, fixate, or approximate tissue.

In a further aspect, the invention is directed to a suturing instrumentincluding an elongate body member, a needle deployment mechanism, and aplurality of depth adaptors. The elongate body member includes a distalportion that defines an opening. The needle deployment mechanism is atleast partially disposed within the elongate body member and isconfigured to move a needle out of the suturing instrument and intotissue of a patient. Each of the plurality of depth adaptors is capableof being removably disposed in the opening to control the penetrationdepth of the needle. Further, each of the plurality of depth adaptorsallows the needle to penetrate a tissue at a different penetration depthand can include a color or other markings to identify its size orpenetrating depth.

In various embodiments, the suturing instrument may further include aneedle deployment mechanism. The needle deployment mechanism is coupledto the needle and is at least partially disposed within the elongatebody member. The needle deployment mechanism moves the needle out of thesuturing instrument and into tissue. In one embodiment, the needledeployment mechanism may also include a needle carrier, and an actuatorcoupled to the needle carrier. The actuator may be disposed at leastpartially in a proximal portion of the elongate body member.

In additional embodiments, the elongate body member includes one or morebends. The suturing instrument can be adapted to access remote organs ortissue within a body. The distal portion of the elongate body member canbe rotatable relative to a remainder of the elongate body member.Further, the suturing instrument may include a handle disposed oppositethe distal portion of the elongate body member. The handle can at leastpartially house the needle deployment mechanism.

Disclosed suturing instruments can be used to perform various medialprocedures within a pelvic region of a patient. In one embodiment, asuturing instrument is used to secure a suture to the sacrospinousligament on a one side of the pelvic region. The suturing instrumentthen can be used to secure a second suture the sacrospinous ligament onthe opposite side of the pelvic region. The first suture is then securedto the vaginal apex at a first location and the second suture is securedto the vaginal apex at a second location. Finally, the two sutures aretensioned such that the vaginal apex is approximated to the sacrospinousligaments on either side of the pelvic region. The suture preferablydoes not penetrate through the entire thickness of the vaginal wall suchthat the two ends of the suture can be knotted within an anteriorincision instead of within the vaginal lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

A fuller understanding of the aspects, objects, features, and advantagesof certain embodiments according to the invention will be obtained andunderstood from the following description when read together with theaccompanying drawings, which primarily illustrate the principles of theinvention and embodiments thereof. The drawings are not necessarily toscale and like reference characters denote corresponding or relatedparts throughout the several views. The drawings and the disclosedembodiments of the invention are exemplary only and not limiting on theinvention.

FIG. 1A is a schematic perspective view of one embodiment of a suturinginstrument in accordance with the invention.

FIG. 1B is a schematic cross-sectional views of the proximal portion ofthe suturing instrument of FIG. 1A.

FIG. 1C is a schematic cross-sectional view of a distal portion of asuturing instrument in accordance with one exemplary embodiment of theinvention.

FIGS. 2A and 2B are enlarged cross-sectional views of the distal portionof the suturing instrument of FIG. 1A.

FIG. 2C is an enlarged cross-sectional view of alternative embodiment ofa suturing instrument in accordance with the invention.

FIG. 2D is a schematic top view of the suturing instrument of FIG. 2Ctaken at line D-D.

FIG. 3A is a schematic plan view of a needle coupled to a suture for usein a suturing instrument in accordance with the invention.

FIG. 3B is a schematic perspective view of a needle catch for use withthe suturing instrument of FIG. 1A.

FIGS. 4A-4E are partial schematic cross-sectional views of the distalportion of the suturing instrument of FIG. 1A during various operationalphases.

FIG. 5 is a front view of an implant assembly partially secured within apelvic region of a patient.

FIG. 6A. is a schematic perspective view of a depth adaptor for use withthe suturing instrument of FIG. 1A.

FIG. 6B is a side view of the depth adaptor of FIG. 6A being insertedinto a suturing instrument.

FIG. 6C is a side view of a suturing instrument with the depth adaptorin place.

FIG. 7 is a side view of a suturing instrument with the depth adaptor inplace being used to place a suture through the vaginal wall.

FIG. 8 is a schematic view of a suturing instrument with the depthadaptor in place being used in a uterine preservation procedure.

DESCRIPTION

As indicated above, the present invention relates to devices and methodsfor treating various pelvic dysfunctions including repairing uterineprolapse, cystoceles, rectoceles, and vaginal vault prolapse. FIG. 1Adepicts a suturing instrument 100 including a handle 102, an elongatebody member 104, and a needle deployment mechanism 110. The suturinginstrument could take a variety of forms. For example, the suturinginstrument 100 could be one of Boston Scientific Corporation suturinginstrument, in particular, the Capio® Open Access and Standard SutureCapturing Devices. The suturing instrument 100 also includes a distalportion 106 and a proximal portion 108. The elongate body member 104 ismechanically coupled to the handle 102 at the proximal portion 108, andthe suturing components are at least partially disposed within thedistal portion 106 of the suturing instrument 100.

The handle 102 could take a variety of forms, for example, the handle102 could be one of the types used with Boston Scientific Corporationsuturing systems, in particular the Capio® Push & Catch suturing system.Generally, the needle deployment mechanism 110 extends longitudinallythrough the elongate body member 104 to the distal portion 106 of thesuturing instrument 100, where the needle deployment mechanism 110 iscoupled to a needle 128 (FIG. 3A). The needle deployment mechanism 110moves the needle 128 between a retracted position and a deployedposition. The needle deployment mechanism 110 is shown in greater detailin FIGS. 1B and 1C.

Referring to FIG. 1B, the proximal portion 108 of the suturinginstrument 100 includes the handle 102, the elongate body member 104, asuture clip 144, and the needle deployment mechanism 110. The sutureclip 144 may be coupled to the handle 102 or the elongate body member104 and is used to hold an end of one or more sutures prior to placementin a patient. The needle deployment mechanism 110 includes an actuator112 (button 117, shaft 116), a bearing 118, a button end 119, and a hole121. The bearing 118 rides along a cylindrical surface 105 that isformed by the inside diameter of the elongate body member 104. Awireform 103 is inserted into the hole 121, coupling it to the actuatorbutton 117. A spring 115 encircles the wireform 103, abuts the buttonend 119, and is compressed between the button end 119 and a springwasher 113. The spring washer 113 is seated upon a center tube 107. Thecenter tube 107 is housed by the cylindrical surface 105 and isconstrained in the distal portion 106. A pusher wire 111 is attached tothe wireform 103 by means of a weld, a coupling, adhesive or othermeans, and is slidably disposed within a guidance sleeve 109, the sleeve109 being disposed within a cylindrical surface 123 formed by the insidediameter of the center tube 107. In one embodiment, the pusher wire 111is constructed of Nitinol (nickel-titanium alloy), so chosen for itscombination of properties that allow for bendability and high columnstrength when constrained.

Referring to FIG. 1C, the distal portion 106 of the elongate body member104 includes a raised portion (or protuberance) 131 and a curved portion126 including a knot pusher 184. The raised portion 131 includes aneedle catch 122. The curved portion 126 defines a needle exit port 120and a suture slot 146. The curved portion 126 also defines an opening176 for receiving tissue. Referring again to the needle deploymentmechanism 110, the pusher wire 111 is attached by welding or other meansto a coupling 150, which is slidably disposed within a track 152. Thecoupling 150 is attached to a carrier wire 154, which by virtue of itsattachment to the coupling 150 is also slidably disposed within thetrack 152. The carrier wire 154 is mechanically coupled to an extendableneedle carrier 124 by means of a weld, a coupling, adhesives, or othermeans. The coupling 150 abuts a backstop washer 156 that is slidablydisposed about the pusher wire 111 and is contained within a pocket 160that includes a back wall 162, against which the backstop washer 156rests. The track 152 terminates distally in a pocket 164 that includes awall 166. A downstop washer 158 is slidably disposed about the carrierwire 154 and constrained within the pocket 164.

In some embodiments, the suturing instrument 100 may include thearticulation mechanism 114. The articulation mechanism 114 is disposedin the elongate body member 104 proximate the distal portion 106 (FIG.1C). The articulation mechanism 114 facilitates the rotation (in thedirections indicated by arrow 182) and positioning of the distal end 106of the suturing instrument 100. In addition, the elongate body 104 canbe substantially linear or may include one or more bends. Thearticulation mechanism 114 and/or bend(s) can facilitate access to deepand/or difficult to reach areas within the patient.

Referring to FIGS. 2A and 2B, in one embodiment, the curved portion 126defines a channel 178, an opening (or needle exit port 120), a needleinput/output slot 142, and a suture slot 146. A needle carrier 124 isdisposed within the channel 178 in the curved portion 126. A distalportion 180 of the needle carrier 124 defines a lumen 138 for holding aneedle 128. The curved portion 126 also defines an opening 176 forreceiving tissue. In an alternative embodiment (FIGS. 2C and 2D), thecurved portion 126 defines a tunnel or needle compartment 140 forholding a plurality of needles 128 a, 128 b, 128 c (generally needle128).

Referring to FIG. 3A, in one embodiment, the needle 128 includes a tip130 and a shaft 134 coupled to the tip 130, thereby forming a shoulder132. The shaft 134 is coupled to a suture 136 a, 136 b, 136 c (generallysuture 136). The needle 128 is inserted into the lumen 138 and held by aslight friction fit. The suture 136 extends out of a needle carriersuture slot 148 and the suture slot 146. Needles 128 b and 128 c arestored in the needle compartment 140 prior to being deployed.

Referring again to FIGS. 1B, 1C, 2A, and 2B, in operation, a user (suchas a physician or other medical personnel) actuates the needledeployment mechanism 110 by pushing on the button 117, which via theattachment to the wireform 103 which is attached to the pusher wire 111,moves the coupling 150 along the track 152 concomitantly moving thecarrier wire 154, which slidably moves the needle carrier 124 throughthe needle exit port 120. The user continues to push the button 117until the needle 128 enters the needle catch 122. The needle catch 122,as shown in FIG. 3B, includes openings 170 defined by successive ribs172. The needle catch 122 receives the needle 128 (coupled to the suture136) through opening 170, the ribs 172 deflect slightly to allow theneedle 128 to pass through. After the formed shoulder 132 has passed theribs 172, the ribs 172 spring back to their original position definingthe openings 170, and the needle 128 remains captured in the needlecatch 122. The user releases the button 117 and the spring 115 urges thebutton 117 proximally, moving the pusher wire 111, the coupling 150, thecarrier wire 154, and the needle carrier 124 proximally along with thebutton 117 to the retracted position. As the needle carrier 124 movesback to the retracted position, the needle 128 slides out of the lumen138. The openings 170 are chosen to be smaller in dimension than theformed shoulder 132. This causes the needle catch 122 to retain theneedle 128 because the flat rear surface of the shoulder 132 preventsthe needle 128 from passing back through the opening 170. When it isnecessary to remove the needle 128 from the needle catch 122, the needle128 may be moved toward an enlarged portion 174 of opening 172. Theenlarged portion 174 is sized to allow the formed shoulder 132 to passthrough without resistance. The needle catch 122 is preferablyconstructed of thin stainless steel of high temper, such as ANSI 301full hard. The needle catch 122 may be fabricated by means of stamping,laser machining, or chemical etching.

The suturing instrument's component materials should be biocompatible.For example, the handle 102, the elongate body member 104, and portionsof the needle deployment mechanism 110 may be fabricated from extruded,molded, or machined plastic material(s), such as polypropylene,polycarbonate, or glass-filled polycarbonate. Other components, forexample the needle 128, may be made of stainless steel. Other suitablematerials will be apparent to those skilled in the art. The material(s)used to form the suture should be biocompatible. The surgeon will selectthe length, diameter, and characteristics of the suture to suit aparticular application. Additionally, the mechanical components andoperation are similar in nature to those disclosed in U.S. Pat. Nos.5,364,408 and 6,048,351, each of which is incorporated by referenceherein in its entirety.

Referring to FIGS. 2A-2B and 4A-4E, the present invention enables a userto place multiple sutures 136 in a patient without removing the suturinginstrument 100 from the patient. The user loads the suture 136 c throughthe first suture slot 146 a until the suture 136 c emerges from thesecond suture slot 146 b. The user then inserts the needle 128 c throughthe needle input/output slot 142 into the needle compartment 140. Theuser repeats this process for additional sutures 136 and needles 128.The user can repeat this process for loading the first suture 136 a andthe first needle 128 a, or the user can insert the first needle 128 adirectly into the needle carrier 124. In either case, the sutures 136 a,136 b, 136 c extend out of the second suture slot 146 b. If the needle128 a is loaded into the needle compartment 140, the user pulls on thefirst suture 136 a (held by the suture clip 144) to cause the firstneedle 128 a to slide down an inclined needle shelf 204 and out of theneedle compartment 140 through the needle output slot 142 into the lumen138 of the needle carrier 124. The suture 136 a extends out of theneedle suture slot 148 and the second suture slot 146 b.

In another embodiment, the suture 136 a could be pulled by attaching thesuture 136 a to a spool mounted on the elongate body member 104 andwinding the spool. In still other embodiments, the suture 136 a could bepulled by other mechanical means known in the art, such as by a lever,for example. After the needles 128 a, 128 b, 128 c and sutures 136 a,136 b, 136 c are loaded into the suturing instrument 100, portions ofthe sutures 136 a, 136 b, 136 c extending out the suture slot 146 b areheld by the suture clip 144 (FIG. 1B). The needle carrier 124, which ispart of the needle deployment mechanism 110, is sequentially connectableto the needles 128 stored in the needle compartment 140. This means thateach needle 128 stored in the needle compartment 140 is connected to,and then deployed by, the needle carrier 124 one at a time in the orderthe needles 128 are dispensed from the needle compartment 140.

The user then inserts the elongate body member 104 into a patient andorients the elongate body member 104 so that the needle exit port 120 isproximate to or in contact with the tissue 206 to be sutured. The userthen pushes the button 117 (FIG. 1B), as described above. Pushing thebutton 117 causes the needle carrier 124 (holding the first needle 128a) to extend out of the needle exit port 120 and push the needle 128 athrough the tissue 206. As the first needle 128 a is pushed through thetissue 206, the first needle 128 a pulls the first suture 136 a throughthe tissue 206. As the user continues to push the button 117, the needlecarrier 124 continues to advance out of the needle exit port 120 anddirects the first needle 128 a and the first suture 136 a toward theneedle catch 122. The user continues to push the button 117 until thefirst needle 128 a contacts and becomes captured by the needle catch 122(FIG. 4B). The user then retracts the needle carrier 124 by releasingthe button 117, as previously described.

After the user retracts the needle carrier 124, the first needle 128 aand the first suture 136 a are left captured within the needle catch122, with the first suture 136 a extending through the tissue 206 (FIG.4C). When the needle carrier 124 returns to a fully retracted position,the user pulls on the second suture 136 b to cause the second needle 128b to slide down the inclined needle shelf 204 and out of the needlecompartment 140 through the needle input/output slot 142 and into thelumen 138 of the needle carrier 124. The second suture 136 b extends outof the needle carrier suture slot 148 and the second suture slot 146 b.The user then advances the needle carrier 124 as described above untilthe second needle 128 b is captured by the needle catch 122 (FIG. 4D).The user then retracts the needle carrier 124 as described above leavingthe second needle 128 b and the second suture 136 b captured by theneedle catch 122 (FIG. 4E). This procedure can be repeated for the thirdneedle 128 c, or for as many needles as may be stored in the needlecompartment 140.

After one or more sutures 136 have been placed, the user withdraws thesuturing instrument 100 from the patient. The user detaches thesuture(s) 136 from the needle(s) 128 and ties a knot or knots into thesuture(s) 136. The user can then use the knot pusher 184 to push theknot(s) into the patient as the knot(s) is tightened.

The suturing instrument 100 described herein can be used to pass suturesthrough bodily tissue during a procedure to repair uterine prolapse.Various methods for treating various pelvic dysfunctions includingprocedures to repair uterine prolapse have been described in U.S. PatentApplication Ser. No. 61/017,257, filed Dec. 28, 2007 to Chu et al.,which is incorporated herein by reference in its entirety. For example,one way to repair or correct uterine prolapse includes using sutures tosuspend the uterus in an anatomically correct position. The uterus issuspended by sutures that are passed through the vaginal wall. Incertain circumstances such as, for example, grade two prolapse (smallprolapse), passing sutures through the vaginal wall with a free needleand needle driver is often difficult as there is limited space to workin. There are various delivery devices that can be used to insert ordeliver a portion or all of an implant assembly into a pelvic region. Adelivery device can be a suturing-type device that can be used to passan end of a suture of an implant assembly through a pelvic tissue. Thedelivery device can be, for example, the Capio device manufactured byBoston Scientific Corporation (also referred to herein as a “Capio” or“Capio device” or “Capio delivery device”). An example of such asuturing delivery device is also described in U.S. Pat. No. 5,741,277 toGordon et al., and U.S. Pat. No. 7,122,039 to Chu, the disclosures ofwhich are hereby incorporated by reference in their entirety. The pelvictissues can be, for example, a sacrospinous ligament, a tendineus archof levator muscle, an obturator muscle, an iliococcygeus muscle or anyother anatomical structure or tissue within a pelvis.

Referring now to FIG. 5, a front view of a pelvic region is shown thatincludes a representation of a uterus U, sacrospinous ligaments SSL, avagina V, a vaginal apex VA, the arcus tendineus AT, obturators O,ischial spines I, and a cervix C for reference. This embodimentillustrates an implant assembly 2220 that can be secured to thesacrospinous ligament SSL for repair of a grade two prolapse that can bedelivered using suturing type delivery device (e.g., a Capio device). Inthis embodiment, the sutures 2224, 2224′ are shown placed through thesacrospinous ligament SSL on opposites sides of the uterus U and theimplant 2222 partially drawn to the sacrospinous ligament SSL. In anactual procedure, however, when the loop or noose 2240, 2240′ is closedor tightened, the implant 2222 would be in contact with the sacrospinousligament. As the sutures 2224, 2224′ are tightened and knotted to thevaginal apex VA, a device, such as a tenaculum clamp, can be used tomove or approximate the vaginal apex VA to the uterus U. In thisembodiment, the ends 2232, 2230 of the sutures 2224, 2224′ are passedthrough the wall of the vaginal apex VA for securement thereto. A firstknot can be tied in the vagina after the sutures have been tensioned. Aphysician can use a finger to push the knot down into the vagina V, aswell as to assist in repositioning the vagina deep in the pelvic region.During the procedure, a backstop can be inserted between the bodilytissue and another portion of the body, such as the bladder of thepatient, to prevent inadvertent puncture of such other portion of thebody.

Methods by which a suture is passed through the entire vaginal wall andknotted within the vaginal lumen may not be desirable if the patient issexually active. One alternative is to use absorbable sutures such thatthe knots would be absorbed during the healing period, however this doesnot provide a permanent solution in cases where tissue ingrowth is weak.

Referring now to FIGS. 6A-6C, an adaptor 250 is shown to be used inconjunction with the suturing instrument 100 to control the depth ofbite of the suture. For example, in certain uterine preservationprocedures, the adaptor 250 can be used with the suturing instrument 100to pass the suture through the internal epithelium of the vaginal walland not through the entire thickness of the vaginal wall such that thetwo ends of the suture are knotted within the anterior incision toapproximate the vaginal apex and the sacrospinous ligament. Permanentsutures can be used in this case to provide a permanent approximationbetween the vaginal apex and sacrospinous ligament. In cases wheretissue ingrowth is weak, permanent sutures maintain the approximation ofthe vagina apex and sacrospinous ligament unless absorbable sutures. Inaddition, sutures and suture knots that are not exposed in the vaginallumen are more likely not to develop complications such as points ofinfection or points of erosions.

FIG. 6B illustrates one embodiment of the adaptor 250 shown beinginserted into the opening 176 of the suturing instrument 100. As shown,the adaptor 250 has two snaps 252 a, 252 b (collectively 252) to secureit in place. The leading edge 254 is inserted into the opening 176 inthe direction indicated by arrow A. Then it is rotated in the opening176 in the direction indicated by arrow B until the snaps 252 engage thesuturing instrument 100. FIG. 6C illustrates the suturing instrument 100with the depth adaptor 250 in place. The adaptor 250 can be removed fromthe suturing instrument 100 by depressing the snaps 252 in the directionindicated by arrow C and then rotating the adaptor 250 in the oppositedirection of arrow B. The adaptor 250 can be made from a biocompatiblematerial such as, for example, extruded, molded, or machined plasticmaterial(s), such as polypropylene, polycarbonate, or glass-filledpolycarbonate. Furthermore, additional sizes and shapes can be used, aswell as different attachment mechanisms to secure the adaptor 250 in theopening 176.

FIG. 7 illustrates the suturing instrument 100 with the adaptor 250 inplace being used to place a suture through the vaginal wall. During use,the suturing instrument 100 is pressed against the tissue T to besutured (as indicated by arrow A in FIG. 7) and the adaptor 250 preventsthe tissue T from entering the opening 176, thus controlling the depthof bite of the needle carrier 124. In this embodiment the adaptor 250 issized such that the needle carrier 124 does not penetrate through theentire thickness T of the vaginal wall. The suture is shown entering onside 1 S1 of the tissue T, not penetrating through side 2 S2, andexiting back through side 1 S1. In other embodiments the adaptor 250 issized to penetrate through the entire thickness T of the vaginal walli.e., the suture can enter the tissue T at side 1 S1, exit side 2 S2,reenter side 2 S2, and exit at side 1 S1. In other embodiments theadaptor 250 is sized to control the depth of penetration (i.e., depth ofbite) into tissue, for example, to prevent inadvertent punctures intobones, organs, tendons, or other tissue. The adaptor 250 can be opaque,translucent, or transparent to allow for visualization in placement ofthe suturing device onto tissue. In alternative embodiments, thesuturing instrument can include a plurality of adaptors 250 that caninclude color coding or other markings to identify its size orpenetrating depth.

In one example of a uterine preservation procedure, the suturinginstrument 100 is used to access and place a suture through thesacrospinous ligament on one side of the pelvic region without theadaptor 250 in place. The adaptor 250 is then inserted into the deviceto aid in the placement of the suture into the vaginal apex. Asdescribed above, the adaptor 250 prevents the needle carrier 124 frompassing too deep, or entirely though the vaginal wall at the apex. Theprocedure is then repeated with a second suture on the other side of thepelvic region. Suspension of the vagina by the vaginal apex to thesacrospinous ligament after vaginal surgery will aid in the patient'srecovery, preventing inadvertent movement or displacement of the vaginaduring the healing or tissue ingrowth period. The suturing instrument100 with the adaptor 250 is not limited for use in uterine prolapseprocedure and can be used in other pelvic floor repairs such as vaginalvault prolapse and cystocele repair or various other surgicalprocedures.

FIG. 8 is an illustration of the suturing instrument 100 with theadaptor 250 in place being used during a uterine preservation procedureto suture to the vaginal apex. The vagina is shown prolapsed (andinverted) with an anterior incision AI made. With the suture 136 loadedsuturing instrument 100 is placed into the anterior incision AI andpositioned over the intended target such as, for example, 2 centimeterslateral to the midline of the cervix C. The needle deployment mechanismis activated to place the suture 136 through side 1 S1 of the vaginalwall VW, but not through side 2 S2, and then exits back through to side1 S1. In this embodiment, side 1 S1 is the interior side of the anteriorincision AI where the knot can be tied to secure the vaginal apex to thesacrospinous ligament.

Other embodiments incorporating the concepts disclosed herein may beused without departing from the spirit and scope of the invention. Thedescribed embodiments are to be considered in all respects as onlyillustrative and not restrictive.

What is claimed is:
 1. A suturing instrument comprising: an elongatebody member including a distal portion defining a first opening, thedistal portion having a curved portion defining a second opening; aneedle deployment mechanism disposed at least partially within theelongate body member for moving a needle out of the suturing instrumentinto tissue; and a depth adaptor configured to control the depth thatthe needle penetrates into the tissue, the depth adaptor having acoupling portion configured to engage a portion of the elongate bodymember to removably couple the depth adaptor to the elongate body membersuch that at least a portion of the depth adaptor is disposed within thesecond opening and configured to contact bodily tissue while disposedwithin the second opening.
 2. The suturing instrument of claim 1 whereinthe needle deployment mechanism comprises: a needle carrier; and anactuator coupled to the needle carrier, the actuator disposed in aproximal portion of the elongate body member.
 3. The suturing instrumentof claim 1 further comprising a needle catch disposed on the distalportion of the elongate body member and configured to receive theneedle.
 4. The suturing instrument of claim 1 wherein the elongate bodymember includes a bend.
 5. The suturing instrument of claim 1 whereinthe elongate body member includes two bends.
 6. The suturing instrumentof claim 1 further comprising a handle disposed opposite the distalportion of the elongate body member, the handle at least partiallyhouses the needle deployment mechanism.
 7. The suturing instrument ofclaim 1 wherein the elongate body member is adapted to access remoteorgans or tissue within a body.
 8. The suturing instrument of claim 1wherein the distal portion of the elongate body member can rotaterelative to a remainder of the elongate body member.
 9. The suturinginstrument of claim 1, wherein the coupling portion includes a snapmember.
 10. The suturing instrument of claim 1, wherein the needledeployment mechanism is configured to be removably coupled to theneedle.
 11. The suturing instrument of claim 1, the coupling portion ofthe depth adaptor being a first coupling portion, wherein the elongatebody has a first outer surface and a second outer surface, the couplingportion having a second coupling portion, the first coupling portionbeing configured to engage the first outer surface, the second couplingportion being configured to engage the second outer surface.
 12. Thesuturing instrument of claim 1, the coupling portion of the depthadaptor being a first coupling portion, wherein the elongate body has afirst outer surface and a second outer surface disposed opposite thefirst outer surface, the coupling portion having a second couplingportion, the first coupling portion being configured to engage the firstouter surface, the second coupling portion being configured to engagethe second outer surface.
 13. A suturing instrument comprising: anelongate body member including a distal portion defining a firstopening, the elongate body member having a curved portion that defines asecond opening; a needle deployment mechanism at least partiallydisposed within the elongate body member for moving a needle out of thesuturing instrument into tissue; and a plurality of depth adaptors, eachdepth adaptor capable of being removably disposed in the opening tocontrol the penetration depth of the needle, each of the plurality ofdepth adaptors having a coupling portion configured to engage a portionof the elongate body member to removably couple each of the plurality ofdepth adaptors to the elongate body member, such that at least a portionof each of the plurality of depth adaptors is configured to be disposedwithin the second opening and configured to contact bodily tissue whiledisposed within the second opening.
 14. The suturing instrument of claim13 wherein each of the plurality of depth adaptors allows the needle topenetrate a tissue at a different penetration depth.
 15. The suturinginstrument of claim 14 wherein each of the plurality of depth adaptorsinclude a color to identify the penetration depth.
 16. The suturinginstrument of claim 13 further comprising a needle deployment mechanismcoupled to the needle and disposed at least partially within theelongate body member for moving the needle out of the suturinginstrument into tissue.
 17. The suturing instrument of claim 16 whereinthe needle deployment mechanism comprises: a needle carrier; and anactuator coupled to the needle carrier, the actuator disposed in aproximal portion of the elongate body member.
 18. The suturinginstrument of claim 16 further comprising a handle disposed opposite thedistal portion of the elongate body member, the handle at leastpartially houses the needle deployment mechanism.
 19. The suturinginstrument of claim 13 wherein the elongate body member includes a bend.20. The suturing instrument of claim 13 wherein the elongate body memberincludes two bends.
 21. The suturing instrument of claim 13 wherein theelongate body member is adapted to access remote organs or tissue withina body.
 22. The suturing instrument of claim 13 wherein the distalportion of the elongate body member can rotate relative to a remainderof the elongate body member.